Houston, Texas 77030


Purpose:

The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help to control BK viral infection and JC viral infection. Researchers also want to learn about the safety of giving CTLs to patients with BK and/or JC infection. CTLs are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections. This is an investigational study. The use of CTLs to treat BK infection and JC infection is not FDA-approved or commercially available. CTLs are currently being used for research purposes only. Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.


Study summary:

CTL Administration: If you are found to be eligible to take part in this study, you will receive the CTLs by vein (also called an infusion) over about 30 minutes. You will stay in the clinic for about 1 hour after the CTL infusion so that you can be checked on for any side effects you may have. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. If the doctor thinks it is in your best interest, you will receive another infusion of CTLs at least 2 weeks after your first infusion. You may receive up to 8 infusions. If you receive multiple infusions of CTLs, there will be at least 2 weeks between each infusion. Study Visits for Patients with BK Infection: Within 1 week before the infusion: - You will have a physical exam. - Blood (about 2 tablespoons) and urine will be collected for routine tests and to check for BK infection. Within 72 hours before the infusion: - Blood (about 2 tablespoons) will be drawn for routine tests. - Urine will be collected for routine tests within 72 hours after the infusion. - You will have a chest x-ray to check for infection. If you have not previously had blood drawn for HLA typing, some of the blood drawn before treatment will be used for HLA typing. HLA typing is used to select the donated CTLs for your infusion that best match your HLA type. Right before the infusion and then at Weeks 2 and 4 and Months 3 and 6 after the infusion: - Blood (about 4 tablespoons) will be drawn to learn about the way T-cells (a type of white blood cell) are working in your body. - You will complete a questionnaire about your symptoms. The questionnaire should take only a few minutes to complete each time. Right before the infusion and then at Weeks 1, 2, 3, 4, at 45 days, and at Months 3, 6, and 12 after the infusion, you will have a physical exam. During the physical exam, you will be checked for possible reactions to the study drug, including graft versus host disease (GVHD) every week from Week 1 until Week 6 after the infusion. GVHD occurs when donor cells attack the cells of the person receiving the CTL infusion. During Weeks 1-4 and then Months 3 and 6 after the infusion, blood (about 4 tablespoons) will be drawn 1 time each week for routine tests and to check for BK infection. Starting after the infusion, you may have the blood tests done either at MD Anderson or your local oncologist's office. If they are performed locally, the results will be sent to the study staff. The study staff will discuss this option with you. Study Visits for Patients with JC Infection: Within 1 week before the infusion: - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - You will have a chest x-ray and MRI to check the status of the infection. - You will have a lumbar puncture to check the status of the infection. To perform a lumbar puncture (also called a spinal tap), a special needle is inserted into the lower back through the space between the bones. The needle is used to draw a sample of the fluid that surrounds the spinal cord. Within 72 hours before the infusion: - Blood (about 2 tablespoons) will be drawn for routine tests. - You will have a chest x-ray. - If you have BK infection, urine will be collected for routine tests and to check for BK infection. Right before the infusion and then at Weeks 1-6 and Months 3, 6, and 12 after the infusion, you will have a physical exam. During the physical exam, you will be checked for possible reactions to the study drug, including GVHD every week during Weeks 1-6. During Weeks 1-4 and then Months 3 and 6 after the infusion, blood (about 4 tablespoons) will be drawn 1 time each week for routine tests and to check for JC infection. Right before the infusion and then at Weeks 1, 3, 5, 7, 9, 11, and then at Months 6 and 12, blood (about 4 tablespoons) will be drawn to learn about the way T-cells (a type of white blood cell) are working in your body. Starting after the infusion, you may have the blood tests, lumbar punctures, and MRIs done either at MD Anderson or your local oncologist's office. If they are performed locally, the results will be sent to the study staff. The study staff will discuss this option with you. Length of Study: You will no longer be able to receive the CTL infusion(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on this study will be over after 1 year.


Criteria:

Inclusion Criteria: 1. Patients with any type of malignancies; and/or HIV/AIDs; and/or history of solid organ transplant. 2. Patients with microscopic hematuria and urine or blood PCR positive for BK virus and/or JC viral encephalitis. 3. Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone. 4. Patients who are currently receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion. 5. Written informed consent and/or signed assent from patient, parent or guardian. 6. Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study. Exclusion Criteria: 1. Patients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received ATG within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment. 2. Patients with other uncontrolled infections (except HIV/AIDS). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 3. Patients with active acute GVHD grades II-IV.


NCT ID:

NCT02479698


Primary Contact:

Principal Investigator
Amanda L. Olson, MD
M.D. Anderson Cancer Center

Amanda L. Olson, MD
Phone: 713-792-8750


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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